Quality and Certifications

We are proud of our quality track record: GLP/GMP-certified, GCP compliant, inspected by EMA, FDA, relevant health authorities and periodic client audits. Our three EU sites are systematically monitored by Corporate Quality Assurance to uphold a unified quality system across the group. All analytical work and processes are regulated by Standard Operating Procedures (SOP) in compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP). A LIMS system is implemented for instruments integration, data integrity and traceability. We are Certified EU Importers of medicinal products with Quality Control managers for batch testing and Qualified Persons (QPs) for batch release certification.

Our latest FDA inspections were successfully completed on May 2020 (Kymos; FEI #3008661256) and April 2019 (Pharmaprogress; FEI #3002860914).

Kymos Certifications

FDA Inspection
(VAI letter)

GLP
Certificate

GMP
Certificate

GMP Audit
Certificate

Manufacturer´s & Importer´s Authorization

Crédit Impôt
Recherche

Innovative
SME stamp

Lebanon Reference Lab for Biologics

Pharmaprogress Certifications

FDA Inspection
(VAI letter)

GMP Certification

Narcotics handling authorization

Clinical samples management authorization

Phase I Center

Prolytic Certifications

GLP
Certificate

Biological Agents Ordinance – BioStoffV – Protection level 3 (**)

Biological Agents Ordinance – BioStoffV
SARS-CoV-2

Find out more about our GLP, GCP and GMP services.

Services

Get in touch

    EU Sites

    Barcelona
    Spain

    Frankfurt
    Germany

    Ancona
    Italy

    EU Offices

    Paris
    France

    Basel
    Switzerland

    Milano
    Italy